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Mom and partner

Not actual patients.

Resources for ZULRESSO

Supporting you and your patients with helpful resources and information.


Additional resources and information

For Healthcare Providers

Sage Central Enrollment Form

Sage Central Enrollment Form

Fax Completed form to 833-564-7243.

For Your Patients

Financial Assistance Brochure

Financial Assistance Brochure

Eligible commercially insured patients may pay as little as $0. Download the ZULRESSO® (brexanolone) Financial Assistance Brochure to review financial support options.

Signs and Symptoms Journal

Signs and Symptoms Journal

This tool can help your patients track the signs and symptoms they may be experiencing to facilitate a conversation with a healthcare provider.

ZULRESSO Patient Brochure.

Looking for more information about ZULRESSO? Download the Patient Brochure or share it.

Zulresso Patient Brochure

Find a Treating Center near you


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Treating Center locator.

Patients can only receive ZULRESSO at a Risk Evaluation and Mitigation Strategy (REMS)-certified Treating Center. Find a ZULRESSO REMS-certified Treating Center near you.

Find a ZULRESSO Treating Center

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Local support finder.

Help your patients with PPD connect with others who've had a similar experience.

Find support near you

FAQs about ZULRESSO
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If you need help finding a Treating Center, the team at SAGE CENTRAL can help.

1-844-4-SAGERX

(1-844-472-4379)

M–F, 8AM–8PM ET

You can also use the locator tool to see where there is a Treating Center near you.

See Treating Centers nearby

In clinical studies, treatment with ZULRESSO was completed in 2.5 days.

ZULRESSO is administered into a patient’s vein by a continuous intravenous (IV) infusion. The infusion lasts 2.5 days, and treatment will take place in a REMS-certified hospital or other healthcare setting. Because of the risk of serious harm resulting from excessive sedation or sudden loss of consciousness during treatment, ZULRESSO is only available through a restricted program called the ZULRESSO REMS in which a healthcare provider will carefully monitor the patient at a certified healthcare facility.

ZULRESSO and some medicines may interact with each other and cause serious side effects.

Ask your patients about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Concomitant use of opioids, antidepressants, or other CNS depressants such as benzodiazepines or alcohols may increase the likelihood or severity of adverse reactions related to sedation. Ask your patients if they drink alcohol or have kidney problems.

Based on findings from animal studies of other drugs that enhance GABAergic inhibition, ZULRESSO may cause fetal harm.

There is a pregnancy exposure registry that monitors pregnancy outcomes in people exposed to antidepressants, including ZULRESSO, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visit https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/.

ZULRESSO can cause serious side effects, including:

Excessive sedation and sudden loss of consciousness. ZULRESSO may cause excessive sedation or loss of consciousness during treatment. Patients should be monitored for symptoms of excessive sleepiness every 2 hours while awake.

Because of these risks, ZULRESSO is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ZULRESSO REMS.

Increased risk of suicidal thoughts or actions. ZULRESSO and other antidepressant medicines may increase suicidal thoughts or actions in some people 24 years of age and younger. Depression or other serious mental illnesses are the most significant causes of suicidal thoughts or actions.

The most common adverse reactions (incidence ≥5% and at least twice the rate of placebo) were sedation/somnolence, dry mouth, loss of consciousness, and flushing/hot flush.

These are not all the side effects of ZULRESSO.

ZULRESSO may cause dizziness and sedation, so patients should not drive or undertake any other dangerous activity until the feeling of sleepiness post-treatment has passed.

Patients should not drink alcohol while receiving ZULRESSO.

ZULRESSO must be administered in a REMS-certified healthcare setting so that you or another healthcare professional will be present to monitor the patient throughout treatment.

In addition, Sage Central is a source for patient support resources and programs, providing information and support to help navigate the treatment journey.

Sage Central provides financial assistance options to eligible patients. Once a patient is enrolled in Sage Central, they will be automatically enrolled in the financial assistance programs for which they may be eligible. Continued eligibility is subject to the satisfaction of the terms and conditions for the financial assistance programs. For more information, including terms and conditions, visit the Sage Central website.


INDICATION

ZULRESSO® is indicated for the treatment of postpartum depression in adults.

IMPORTANT SAFETY INFORMATION

WARNING: EXCESSIVE SEDATION AND SUDDEN LOSS OF CONSCIOUSNESS

Patients treated with ZULRESSO are at risk of excessive sedation or sudden loss of consciousness during administration.

Because of the risk of serious harm, patients must be monitored for excessive sedation and sudden loss of consciousness and have continuous pulse oximetry monitoring. Patients must be accompanied during interactions with their child(ren).

Because of these risks, ZULRESSO is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ZULRESSO REMS.

WARNINGS AND PRECAUTIONS

Excessive Sedation and Sudden Loss of Consciousness

In clinical studies, 5% of ZULRESSO-treated patients compared to 0% of placebo-treated patients experienced sedation and somnolence that required dose interruption or reduction. Loss of consciousness or altered state of consciousness was reported in 4% of ZULRESSO-treated patients compared with 0% of placebo-treated patients.

During the infusion, monitor patients for sedative effects every 2 hours during planned, non-sleep periods. Immediately stop the infusion if there are signs or symptoms of excessive sedation. After symptoms resolve, the infusion may be resumed at the same or lower dose as clinically appropriate. Immediately stop the infusion if pulse oximetry reveals hypoxia. After hypoxia, the infusion should not be resumed.

Concomitant use of opioids, antidepressants, or other CNS depressants such as benzodiazepines or alcohol may increase the likelihood or severity of adverse reactions related to sedation. Patients must be accompanied during interactions with their child(ren) while receiving the infusion because of the potential for excessive sedation and sudden loss of consciousness.

Patients should be cautioned against engaging in potentially hazardous activities requiring mental alertness, such as driving, after infusion until any sedative effects of ZULRESSO have dissipated.

ZULRESSO Risk Evaluation and Mitigation Strategy (REMS)

ZULRESSO is available only through a restricted program under a REMS called the ZULRESSO REMS because excessive sedation or sudden loss of consciousness can result in serious harm.

Notable requirements of the ZULRESSO REMS include:

  • Healthcare facilities must enroll in the program and ensure that ZULRESSO is only administered to patients who are enrolled in the
    ZULRESSO REMS
  • Pharmacies must be certified with the program and must only dispense ZULRESSO to healthcare facilities who are certified in the
    ZULRESSO REMS
  • Patients must be enrolled in the ZULRESSO REMS prior to administration of ZULRESSO
  • Wholesalers and distributors must be registered with the program and must only distribute to certified healthcare facilities and pharmacies

Further information, including a list of certified healthcare facilities, is available at www.zulressorems.com or call 1-844-472-4379.

Suicidal Thoughts and Behaviors

In pooled analyses of placebo-controlled trials of chronically administered antidepressant drugs (SSRIs and other antidepressant classes) that include approximately 77,000 adult patients and 4,500 pediatric patients, the incidence of suicidal thoughts and behaviors in antidepressant-treated patients age 24 years and younger was greater than in placebo-treated patients. There was considerable variation in risk of suicidal thoughts and behaviors among drugs, but there was an increased risk identified in young patients for most drugs studied. There were differences in absolute risk of suicidal thoughts and behaviors across the different indications, with the highest incidence in patients with major depressive disorder (MDD).

ZULRESSO does not directly affect monoaminergic systems. Because of this and the comparatively low number of exposures to ZULRESSO, the risk of developing suicidal thoughts and behaviors with ZULRESSO is unknown. If depression becomes worse or patients experience emergent suicidal thoughts and behaviors, consider changing the therapeutic regimen, including discontinuing ZULRESSO.

Adverse Reactions

The most common adverse reactions (incidence ≥5% and at least twice the rate of placebo) were sedation/somnolence, dry mouth, loss of consciousness, and flushing/hot flush.

Use in Specific Populations

  • Pregnancy: Based on findings from animal studies of other drugs that enhance GABAergic inhibition, ZULRESSO may cause fetal harm
  • Lactation: Brexanolone is transferred to breastmilk in nursing mothers. There are no data on the effects of ZULRESSO on a breastfed infant. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ZULRESSO and any potential adverse effects on the breastfed child from ZULRESSO or from the underlying maternal condition
  • Pediatric Use: The safety and effectiveness of ZULRESSO in pediatric patients have not been established
  • Renal Impairment: No dosage adjustment is recommended in patients with mild, moderate, or severe renal impairment. Avoid use of ZULRESSO in patients with end stage renal disease (ESRD)

Controlled Substance

ZULRESSO contains brexanolone, a Schedule IV controlled substance under the Controlled Substances Act.

Please also see Full Prescribing Information including Boxed Warning and Medication Guide for ZULRESSO.

To report SUSPECTED ADVERSE REACTIONS, contact Sage Therapeutics, Inc. at 1-844-4-SAGERX (1-844-472-4379) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

INDICATION
ZULRESSO® is indicated for the treatment of postpartum depression in adults.

IMPORTANT SAFETY INFORMATION
WARNING: EXCESSIVE SEDATION AND SUDDEN LOSS OF CONSCIOUSNESS
Patients treated with ZULRESSO are at risk of excessive sedation or sudden loss of consciousness during administration.
Because of the risk of serious harm, patients must be monitored for excessive sedation and sudden loss of consciousness and have continuous pulse oximetry monitoring. Patients must be accompanied during interactions with their child(ren).
Because of these risks, ZULRESSO is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ZULRESSO REMS.